At MedStar Heart & Vascular Institute, our mission has always been one of advancing knowledge. Despite the pandemic, physicians and researchers continue to look at what we’ve learned about cardiovascular health and how we can share those findings with others.
Ron Waksman, MD, associate director of Cardiology and director of Cardiovascular Research and Advanced Education at the Institute, reflects on how research and clinical trials have been impacted by the virus, and provides a look at the changes that may lie ahead. Bottom line? The beat goes on.
What has been the impact on current studies?
For certain subspecialties—structural heart, for example, in which procedures are generally considered urgent—business and patient recruitment have continued as usual. For other subspecialties, volume is down, as we’ve been limited to emergency cases only. Our team has adapted well to working remotely, so it hasn’t impeded research activity, such as trial design and the functionality of our Cardiovascular Core Lab.
How have researchers incorporated new virtual tools?
In some cases, we’ve enabled remote monitoring and alternative testing methods. We’ve found it quite appropriate for some trials, so much so that it’s something we may continue post-pandemic. In a recent conversation with representatives from the U.S. Food and Drug Administration, virtual tools, such as new applications that track activity and vital signs, were a big part of our discussion and continue to be. This moment is an opportunity to explore how data collection could be made more efficient—and more patient centered—through the adaption of these tools.
We’ve also used telehealth platforms to meet with patients who need to be consented and with families who have questions. It’s helped us ensure regular, ongoing communications.
Finally, we’ve moved our weekly research meeting to a virtual platform. Interestingly, we’ve seen higher numbers of attendees than our previous in-person meetings. We also have clearer visuals and audios that might be harder to see or hear in a large auditorium than on a personal computer. Virtual meetings are certainly something we’re considering maintaining even after we all return to onsite work.
How might the virus, itself, affect trial results?
The pandemic has impacted everyone, including our patients. Therefore, we must consider how to account for and address possible variations due to the virus. To ensure we understand how the virus might affect trial results, we’re taking a few steps, including:
- Changing case report forms to capture COVID-related information: Was the patient infected? Symptomatic? Hospitalized?
- Accounting for behavioral changes such as adherence to diet and exercise programs, medication regimens, as well as changes in quality of life due to anxiety or social distancing.
- Understanding that event rates may be different due to stay-at-home orders or fear of venturing out of home.
Looking ahead, are there plans to study the virus’s impact on the heart?
We’ve initiated several protocols and submitted grants to study the virus’s impact on the cardiovascular system among our patient population. We’re also looking at the specific impact that racial disparities may have on cardiovascular events in people with COVID-19 so we can better understand how to treat and diagnose them. Finally, our research on treatment for COVID-19 positive patients with heart attack has just been accepted for publication by Cardiovascular Revascularization Medicine.
As our hospitals work with national, state, and local officials to follow criteria for resuming non-essential procedures, we will continue to introduce new safety measures for patients and their families, implement widespread COVID-19 testing, and provide increased communication regarding protocol updates. Please contact Dr. Waksman if you have research-related questions: 202-877-2812 [email protected].